Status:
COMPLETED
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System
Lead Sponsor:
Zimmer Biomet
Conditions:
Acetabulum Fracture
Pelvic Ring Fracture
Eligibility:
All Genders
18+ years
Brief Summary
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of...
Detailed Description
The Reconstruction System is especially used to stabilize pelvic ring and acetabulum fractures. One site will be involved in this study. The aim is to include a maximum of 83 consecutive series cases ...
Eligibility Criteria
Inclusion
- Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process
Exclusion
- Off-label use
- Patients under the age of 18
- Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
- Infection
- Metal sensitivity or intolerance
- Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
- Sternal or spinal fractures
- Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
- Patients with inadequate soft tissue coverage at the implant site
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05215626
Start Date
August 1 2022
End Date
December 12 2024
Last Update
January 7 2025
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Senese
Siena, Italy, 53100